Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses.

2.50
Hdl Handle:
http://hdl.handle.net/11287/620723
Title:
Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses.
Authors:
Halpin, David M; Birk, R.; Brealey, N.; Criner, G.J.; Dransfield, M. T.; Hilton, E.; Lomas, D. A.; Zhu, C-Q; Lipson, D. A.
Abstract:
Triple inhaled corticosteroid (ICS)/long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) therapy is recommended for symptomatic patients with chronic obstructive pulmonary disease (COPD) and at risk of exacerbations. However, the benefits versus side-effects of triple inhaled therapy for COPD, based on distinct patient clinical profiles, are unclear. FULFIL, a phase III, randomised, double-blind study, compared 24 weeks of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 µg using the Ellipta inhaler with twice-daily budesonide/formoterol (BUD/FOR) 400/12 µg using the Turbuhaler. Subgroup analyses of forced expiratory volume in 1 s (FEV1), St George's Respiratory Questionnaire (SGRQ) Total score and exacerbation rates were carried out. Subgroups were defined by COPD medication at screening (ICS+LABA, BUD+FOR, ICS+LABA+LAMA, LAMA alone, tiotropium alone and LAMA+LABA), by disease severity (lung function and exacerbations) and by exacerbation history (exacerbation severity and frequency). In the intent-to-treat population (n=1810) at week 24, FF/UMEC/VI (n=911) versus BUD/FOR (n=899) improved FEV1 and SGRQ Total score and reduced mean annual exacerbation rates in all disease severity and exacerbation history subgroups. FF/UMEC/VI versus BUD/FOR improved FEV1 and SGRQ Total score in all medication subgroups and reduced mean annual exacerbation rates in all medication subgroups, except LAMA+LABA. Adverse events were similar across subgroups. These findings support the benefit of FF/UMEC/VI compared with dual ICS/LABA therapy in patients with symptomatic COPD regardless of disease severity or prior treatment and may help to inform clinical decision making.
Citation:
Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses. 2018, 4 (2) ERJ Open Res
Publisher:
European Respiratory Society
Journal:
ERJ open research
Issue Date:
Apr-2018
URI:
http://hdl.handle.net/11287/620723
DOI:
10.1183/23120541.00119-2017
PubMed ID:
29750142
Additional Links:
https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/29750142/
Note:
This article is freely available via Open Access. Click on the Additional Link above to access the full-text via the publisher's site.
Type:
Journal Article
Language:
en
ISSN:
2312-0541
Appears in Collections:
Respiratory Medicine; 2018 RD&E publications

Full metadata record

DC FieldValue Language
dc.contributor.authorHalpin, David Men
dc.contributor.authorBirk, R.en
dc.contributor.authorBrealey, N.en
dc.contributor.authorCriner, G.J.en
dc.contributor.authorDransfield, M. T.en
dc.contributor.authorHilton, E.en
dc.contributor.authorLomas, D. A.en
dc.contributor.authorZhu, C-Qen
dc.contributor.authorLipson, D. A.en
dc.date.accessioned2018-06-22T15:36:55Z-
dc.date.available2018-06-22T15:36:55Z-
dc.date.issued2018-04-
dc.identifier.citationSingle-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses. 2018, 4 (2) ERJ Open Resen
dc.identifier.issn2312-0541-
dc.identifier.pmid29750142-
dc.identifier.doi10.1183/23120541.00119-2017-
dc.identifier.urihttp://hdl.handle.net/11287/620723-
dc.description.abstractTriple inhaled corticosteroid (ICS)/long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) therapy is recommended for symptomatic patients with chronic obstructive pulmonary disease (COPD) and at risk of exacerbations. However, the benefits versus side-effects of triple inhaled therapy for COPD, based on distinct patient clinical profiles, are unclear. FULFIL, a phase III, randomised, double-blind study, compared 24 weeks of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 µg using the Ellipta inhaler with twice-daily budesonide/formoterol (BUD/FOR) 400/12 µg using the Turbuhaler. Subgroup analyses of forced expiratory volume in 1 s (FEV1), St George's Respiratory Questionnaire (SGRQ) Total score and exacerbation rates were carried out. Subgroups were defined by COPD medication at screening (ICS+LABA, BUD+FOR, ICS+LABA+LAMA, LAMA alone, tiotropium alone and LAMA+LABA), by disease severity (lung function and exacerbations) and by exacerbation history (exacerbation severity and frequency). In the intent-to-treat population (n=1810) at week 24, FF/UMEC/VI (n=911) versus BUD/FOR (n=899) improved FEV1 and SGRQ Total score and reduced mean annual exacerbation rates in all disease severity and exacerbation history subgroups. FF/UMEC/VI versus BUD/FOR improved FEV1 and SGRQ Total score in all medication subgroups and reduced mean annual exacerbation rates in all medication subgroups, except LAMA+LABA. Adverse events were similar across subgroups. These findings support the benefit of FF/UMEC/VI compared with dual ICS/LABA therapy in patients with symptomatic COPD regardless of disease severity or prior treatment and may help to inform clinical decision making.en
dc.language.isoenen
dc.publisherEuropean Respiratory Societyen
dc.relation.urlhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/29750142/en
dc.rightsArchived with thanks to ERJ open research. The content of this work is copyright of the authors or their employers. Design and branding are copyright ©ERS 2018. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0.en
dc.subjectWessex Classification Subject Headings::Respiratory medicineen
dc.titleSingle-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses.en
dc.typeJournal Articleen
dc.identifier.journalERJ open researchen
dc.description.noteThis article is freely available via Open Access. Click on the Additional Link above to access the full-text via the publisher's site.en
dc.type.versionPublisheden
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